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CDE Detailed Report
This report contains detailed information about the selected CDEs.
Note: If at least one CDE was selected from a copyright- or trademark-protected instrument/scale then all of the CDEs from that instrument/scale are included in this report.
Disease: Traumatic Brain Injury
SubDisease: Comprehensive
Sub-Domain: General Health History
CRF: Significant Medical History
Item count: 15 (15 distinct CDEs)
CDE ID
CDE Name
Variable Name
Definition / Description
Question Text
Permissible Value
Description
Data Type
Instructions
References
Population
Classification (e.g., Core)
Version #
Version Date
Aliases for Variable Name
CRF Module / Guideline
© or TM
Sub-Domain
Domain
Previous Title
Size
Input Restrictions
Min Value
Max Value
Measurement Type
LOINC ID
SNOMED
caDSR ID
CDISC ID
C00324
Concussion prior number
ConcussionPriorNum
Number of prior concussions
Number of concussions prior to the current injury
  
Numeric Values
Response is obtained from report by participant/subject or proxy. Document whether this information was obtained prior to study enrollment or later. Recommend collection as soon as possible after visit/admission.
Michael McCrea, PhD, Thomas Hammeke, PhD, Gary Olsen, MS, Peter Leo, BS, and Kevin Guskiewicz, ATC, PhD. Unreported Concussion in High School Football Players. Clin J Sport Med Volume 14, Number 1, January 2004
Adult;Pediatric
Supplemental
3.0
7/20/2013
Aliases for variable name not defined
Significant Medical History
General Health History
Participant History and Family History
Concussion prior number
 
Free-Form Entry
0
99
     
C00312
Body system category
BodySysCat
Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured interview and physical examination of all the body systems.
Body system category
Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Dermatological;Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Gastrointestinal/Abdominal;Genitourinary;Gynecologic/Urologic/ Renal;Hematologic/Lymphatic;Hepatobiliary;Integumentary (skin and/or breast);Musculoskeletal;Musculoskeletal (separate from ALS exam);Neurological;Neurologic/CNS;Neurological (separate from ALS exam);Oncologic;Psychiatric;Pulmonary;Respiratory;Other, specify:;
Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Dermatological;Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Gastrointestinal/Abdominal;Genitourinary;Gynecologic/Urologic/ Renal;Hematologic/Lymphatic;Hepatobiliary;Integumentary (skin and/or breast);Musculoskeletal;Musculoskeletal (separate from ALS exam);Neurological;Neurologic/CNS;Neurological (separate from ALS exam);Oncologic;Psychiatric;Pulmonary;Respiratory;Other, specify:;
Alphanumeric
Choose one. Response is obtained by report of the participant/subject or proxy as soon as possible after visit/admission. Document the date the history was obtained so it can be determined whether this information was obtained prior to study enrollment or later. Recommend collection at least on date of TBI or at time of first medical treatment. Comorbidity prior to injury may influence the disease course and chances of recovery. Serious comorbidity or comorbidity that may influence the assessment of outcome are generally considered exclusion criteria in randomized clinical trials. It is therefore highly relevant to accurately record the significant relevant medical history.
Review of Symptoms from Centers for Medicare and Medicaid Services https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/eval_mgmt_serv_guide-ICN006764.pdf
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Significant Medical History
General Health History
Participant History and Family History
Body system category
 
Single Pre-Defined Value Selected
     
2002895
 
C18666
Body system other text
BodySysOTH
The free-text field related to 'Body system category' specifying other text. Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured
Other, specify
  
Alphanumeric
Choose one. Response is obtained by report of the participant/subject or proxy as soon as possible after visit/admission. Document the date the history was obtained so it can be determined whether this information was obtained prior to study enrollment or later. Recommend collection at least on date of TBI or at time of first medical treatment. Comorbidity prior to injury may influence the disease course and chances of recovery. Serious comorbidity or comorbidity that may influence the assessment of outcome are generally considered exclusion criteria in randomized clinical trials. It is therefore highly relevant to accurately record the significant relevant medical history.
Review of Symptoms from Centers for Medicare and Medicaid Services https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/eval_mgmt_serv_guide-ICN006764.pdf
Adult;Pediatric
Supplemental
1.0
5/27/2014
Aliases for variable name not defined
Significant Medical History
General Health History
Participant History and Family History
 
4000
Free-Form Entry
     
2002895
 
C00321
Medical history for body system indicator
MedclHistBodySysInd
Indicator of whether the participant/subject has a history of medical problems/conditions for the specific body system.
Does the participant/subject have a history of any medical problems/conditions in the following body systems?
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Choose one. Response is obtained by report of the participant/subject or proxy as soon as possible after visit/admission. Document the date the history was obtained so it can be determined whether this information was obtained prior to study enrollment or later. Recommend collection at least on date of TBI or at time of first medical treatment. Comorbidity prior to injury may influence the disease course and chances of recovery. Serious comorbidity or comorbidity that may influence the assessment of outcome are generally considered exclusion criteria in randomized clinical trials. It is therefore highly relevant to accurately record the significant relevant medical history.
No references available
Adult;Pediatric
Supplemental
3.0
7/22/2013
Aliases for variable name not defined
Significant Medical History
General Health History
Participant History and Family History
Medical history for body system indicator
 
Single Pre-Defined Value Selected
       
C00322
Medical history condition text
MedclHistCondTxt
Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history
Verbatim text for the medical condition reported or documented in the medical record as part of medical history
  
Alphanumeric
Recommend collection at least during initial medical treatment.
This element is recommended for pediatric studies.
SNOMED CT Codes (http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html)
Adult;Pediatric
Core
3.0
7/25/2013
Refer to SCI CDE Annotated Form
Significant Medical History
General Health History
Participant History and Family History
Medical history condition text
4000
Free-Form Entry
     
2003874
 
C00313
Medical history condition SNOMED CT code
MedclHistCondSNOMEDCTCode
Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject
Medical history condition for SNOWMED CT code
  
Alphanumeric
Recommend collection at least during initial medical treatment. This element is recommended for pediatric studies.
SNOMED CT Codes (http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html)
Adult;Pediatric
Core
3.0
7/25/2013
Aliases for variable name not defined
Significant Medical History
General Health History
Participant History and Family History
Medical history condition SNOMED CT code
255
Free-Form Entry
       
C00317
Medical history condition start date and time
MedclHistCondStrtDateTime
Date (and time, if applicable and known) for the start of an event in the participant's/subject's medical history
Medical history condition start date and time
  
Date or Date & Time
Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).
No references available
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Significant Medical History
General Health History
Participant History and Family History
Medical history condition start date and time
 
Free-Form Entry
     
2543596
 
C00319
Medical history condition ongoing indicator
MedclHistCondOngoingInd
Indicator of whether a medical condition/disease experienced by the participant/subject is ongoing
Medical history condition ongoing indicator
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Choose one.
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Significant Medical History
General Health History
Participant History and Family History
Medical history condition ongoing indicator
 
Single Pre-Defined Value Selected
     
2736881
 
C00316
Medical history condition end date and time
MedclHistCondEndDateTime
Date (and time, if applicable and known) for the end of an event in the participant's/subject's medical history
Medical history condition end date and time
  
Date or Date & Time
Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).
No references available
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Significant Medical History
General Health History
Participant History and Family History
Medical history condition end date and time
 
Free-Form Entry
     
3145557
 
C00326
Perinatal neurologic event type
PerinatlNeurolEventTyp
Type of perinatal neurologic injury
Perinatal neurologic event type
Subarachnoid hemorrhage;Intraparenchymal hemorrhage;Intraventricular hemorrhage;Hypoxia;Other, specify;None;Subdural hemorrhage;
Subarachnoid hemorrhage;Intraparenchymal hemorrhage;Intraventricular hemorrhage;Hypoxia;Other, specify;None;Subdural hemorrhage;
Alphanumeric
Choose all that apply. Response is obtained from report by participant/subject or proxy. Document whether this information was obtained prior to study enrollment or later. Recommend collection as soon as possible after visit/admission. This element is recommended for pediatric studies.TBI as a result of the birth process is a common and well-described phenomenon. A recent study of 97 asymptomatic neonates found that 26% of those born vaginally had TBI identified on a 3T MRI performed an average of 21 days after birth. Unlike TBI due to other causes, the locations of the ICH associated with birth are almost exclusively posterior fossa/occipital lobes. Presenting symptoms due to birth-related TBI can range from none to severe and include apnea, bradycardia and/or seizures.
Holden K, Titus M, Van_Tassel P (1999) Cranial magnetic resonance imaging examination of normal term neonates: a pilot study. J Child Neurol 145/9/2011708-710. Pollina J, Dias M, Li V, Kachurek D, Arbesman M (2001) Cranial birth injuries in term newborn infants. Pediatr Neurosurg 35:113-119. Looney C, Smith J, Merck L, Wolfe H, Chescheir N, Hamer R, Gilmore J (2007) Intracranial hemorrhage in asymptomatic neonates: prevalence on MR images and relationship to obstetric and neonatal risk factors. Radiology 242:535-541. Whitby E, Griffiths P, Rutter S, Smith M, Sprigg A, Ohadike P, Davies N, Rigby A, Paley M (Lancet) Frequency and natural history of subdural haemorrhages in babies and relation to obstetric factors. 2004 363:846-851. Towner D, Castro M, Eby-Wilkens E, Gilbert W (1999) Effect of mode of delivery in nulliparous women on neonatal intracranial injury. N Engl J Med 341:1709-1714.
Pediatric
Supplemental
3.0
7/19/2013
Aliases for variable name not defined
Significant Medical History
General Health History
Participant History and Family History
Perinatal neurologic event type
 
Multiple Pre-Defined Values Selected
       
C18745
Perinatal neurologic event other text
PerinatlNeurolEventOTH
The free-text field related to 'Perinatal neurologic event type' specifying other text. Type of perinatal neurologic injury
Other, specify
  
Alphanumeric
Choose all that apply. Response is obtained from report by participant/subject or proxy. Document whether this information was obtained prior to study enrollment or later. Recommend collection as soon as possible after visit/admission. This element is recommended for pediatric studies.TBI as a result of the birth process is a common and well-described phenomenon. A recent study of 97 asymptomatic neonates found that 26% of those born vaginally had TBI identified on a 3T MRI performed an average of 21 days after birth. Unlike TBI due to other causes, the locations of the ICH associated with birth are almost exclusively posterior fossa/occipital lobes. Presenting symptoms due to birth-related TBI can range from none to severe and include apnea, bradycardia and/or seizures.
Holden K, Titus M, Van_Tassel P (1999) Cranial magnetic resonance imaging examination of normal term neonates: a pilot study. J Child Neurol 145/9/2011708-710. Pollina J, Dias M, Li V, Kachurek D, Arbesman M (2001) Cranial birth injuries in term newborn infants. Pediatr Neurosurg 35:113-119. Looney C, Smith J, Merck L, Wolfe H, Chescheir N, Hamer R, Gilmore J (2007) Intracranial hemorrhage in asymptomatic neonates: prevalence on MR images and relationship to obstetric and neonatal risk factors. Radiology 242:535-541. Whitby E, Griffiths P, Rutter S, Smith M, Sprigg A, Ohadike P, Davies N, Rigby A, Paley M (Lancet) Frequency and natural history of subdural haemorrhages in babies and relation to obstetric factors. 2004 363:846-851. Towner D, Castro M, Eby-Wilkens E, Gilbert W (1999) Effect of mode of delivery in nulliparous women on neonatal intracranial injury. N Engl J Med 341:1709-1714.
Pediatric
Supplemental
1.0
5/27/2014
Aliases for variable name not defined
Significant Medical History
General Health History
Participant History and Family History
 
4000
Free-Form Entry
       
C00327
Prior traumatic injury indicator
PriorTraumInjryInd
Indicator of prior traumatic injury found either historically, previous emergency department visits, radiographic findings, or signs or symptoms at time of presentation.
Prior traumatic injury indicator
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Choose one. Document whether this information was obtained prior to study enrollment or later. Recommend collection as soon as possible after visit/admission from subject or proxy. This element is recommended for pediatric studies.
No references available
Adult;Pediatric
Supplemental
3.0
7/19/2013
Aliases for variable name not defined
Significant Medical History
General Health History
Participant History and Family History
Prior traumatic injury indicator
 
Single Pre-Defined Value Selected
       
C00328
Prior traumatic injury type
PriorTraumInjryType
General location of traumatic injury, if evidence of prior traumatic injury
Prior traumatic injury type
Brain Injury;Spine Injury;Other Extracranial Injury;
Brain Injury;Spine Injury;Other Extracranial Injury;
Alphanumeric
Choose all that apply. This element is recommended for pediatric studies.
No references available
Adult;Pediatric
Supplemental
3.0
7/19/2013
Aliases for variable name not defined
Significant Medical History
General Health History
Participant History and Family History
Prior traumatic injury type
 
Multiple Pre-Defined Values Selected
       
C00323
Head injury prior number
HeadInjPriorNum
Number of prior head injuries, if previous TBI history
Head injury prior number
  
Numeric Values
Response is obtained from report by participant/subject or proxy. Document whether this information was obtained prior to study enrollment or later. Recommend collection as soon as possible after visit/admission.
No references available
Adult;Pediatric
Supplemental
3.0
7/20/2013
Aliases for variable name not defined
Significant Medical History
General Health History
Participant History and Family History
Head injury prior number
 
Free-Form Entry
0
99
     
C00325
Blast prior exposure number
BlastPriorExposurNum
Number of blasts the participant has been exposed to prior to his or her current injury.
Blast prior exposure number
  
Numeric Values
This element should be collected in studies including military populations.
Holden K, Titus M, Van_Tassel P (1999) Cranial magnetic resonance imaging examination of normal term neonates: a pilot study. J Child Neurol 145/9/2011708-710. Pollina J, Dias M, Li V, Kachurek D, Arbesman M (2001) Cranial birth injuries in term newborn infants. Pediatr Neurosurg 35:113-119. Looney C, Smith J, Merck L, Wolfe H, Chescheir N, Hamer R, Gilmore J (2007) Intracranial hemorrhage in asymptomatic neonates: prevalence on MR images and relationship to obstetric and neonatal risk factors. Radiology 242:535-541. Whitby E, Griffiths P, Rutter S, Smith M, Sprigg A, Ohadike P, Davies N, Rigby A, Paley M (Lancet) Frequency and natural history of subdural haemorrhages in babies and relation to obstetric factors. 2004 363:846-851. Towner D, Castro M, Eby-Wilkens E, Gilbert W (1999) Effect of mode of delivery in nulliparous women on neonatal intracranial injury. N Engl J Med 341:1709-1714.
Adult;Pediatric
Supplemental
3.0
7/20/2013
Aliases for variable name not defined
Significant Medical History
General Health History
Participant History and Family History
Blast prior exposure number
 
Free-Form Entry
       
12-11-2018
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